Notice of Intent to Publish a Funding Opportunity Announcement for Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a component of the U.S. Department of Health and Human Services and part of the National Institutes of Health (NIH), has issued a Notice of Intent to publish a forthcoming Funding Opportunity Announcement (FOA). The planned FOA, identified as NOT-DK-26-308, will invite applications under a cooperative agreement (U01) mechanism for participation as Clinical Research Centers in the Liver Cirrhosis Network. This initiative supports research efforts that aim to understand and treat liver cirrhosis, a chronic and progressive liver disease with high morbidity and mortality in the United States. The primary aim of the forthcoming FOA is to complete enrollment in two major ongoing studies: the Liver Cirrhosis Network Longitudinal Cohort Study and the Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU), which is a double-blind, randomized, placebo-controlled Phase 2 clinical trial. The renewal opportunity will focus on continuing recruitment, facilitating data collection and analysis, disseminating findings, and supporting ancillary research that complements these efforts. These activities will be coordinated in partnership with the Liver Cirrhosis Network’s Scientific and Data Coordination Center. This opportunity will use the U01 cooperative agreement funding mechanism, which indicates a substantial involvement by NIH staff in the management and oversight of the funded projects. The total estimated program funding is $3,302,147, with a projected award ceiling of $330,214. There will be approximately 10 awards distributed, though the minimum award amount has not been specified. Importantly, there is no cost-sharing or matching requirement for this opportunity. Eligible applicants include a wide range of entities such as special district governments, city or township governments, county governments, state governments, small businesses, Native American tribal governments and organizations, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status (excluding institutions of higher education), and public or Indian housing authorities. This broad eligibility underscores the importance of fostering diverse and collaborative participation in addressing liver cirrhosis research. At this stage, applications are not being solicited, as this is a forecasted opportunity. The estimated publication date for the full FOA is July 11, 2025, with applications due by August 15, 2025. Award notifications and the official project start date are both anticipated for July 1, 2026. This advanced notice is intended to give potential applicants ample time to develop competitive applications and establish meaningful collaborations. Investigators with expertise in liver disease and translational science are particularly encouraged to prepare for submission. For additional information, interested parties may contact Dr. Edward Doo at the National Institute of Diabetes and Digestive and Kidney Diseases. He can be reached by phone at 301-451-4524 or via email at dooe@niddk.nih.gov. This early alert is an opportunity for eligible institutions and researchers to align their resources and prepare for a formal call for proposals in the near future.